Lead a team to successfully over enroll a pivotal phase III study in under a year. Then maintained enrollment and successful database lock during COVID 19.• Provided daily leadership and strategic direction required for the successful execution of all operational aspects of rare disease clinical trials at Amicus.• Directed Global and US clinical trials in adults and pediatrics for Pompe Disease, Phase I to IV. Including vendor management, site selection, oversight monitoring, study start-up, maintenance and close-out activities.• Headed up inspection readiness activities for FDA, EMA and PMDA.• Led the team to successful regulatory inspections by the FDA and EMA that resulted in approval of Pombiliti/Opfolda, a two-component novel therapy for Pompe Disease.• Effectively communicated enrollment metrics and any risks to upper management.• Implemented the use of home infusions and home nursing visits to improve the quality of life for patients.• Oversaw the management of projects to ensure they are conducted in an effective manner, meeting timelines and expectations that are within their control and in adherence with SOPs, appropriate regulations and quality standards.• Provided financial oversite of budgets for clinical operations.• Supported the development and implementation of standards, tools and procedures to improve clinical research efficiency.• Ensured clinical trials are conducted and reported in accordance with GCP/ICH, QC/QA, SOPs, and company Best Practices Guidelines.• Provided appropriate training, mentoring and career development for staff of 12 FTEs in US, and Japan. Optimize staff productivity.

• Provided leadership and strategic direction required for the successful execution of all operational aspects of Pompe clinical trials at Amicus.• Directed Global and US clinical trials in Pompe Disease from start-up to CSR.• Directed the management and maintained strong, effective relationships with vendors, consultants, investigators and other external clinical trial participants that led to enrollment goals being met.• Oversaw the management of projects to ensure they are conducted in an effective manner, meeting timelines and expectations that are within their control and in adherence with SOPs, appropriate regulations and quality standards.• Managed budgets for clinical operations.• Supported the development and implementation of standards, tools and procedures to improve clinical research efficiency.• Ensured clinical trials are conducted and reported in accordance with GCP/ICH, QC/QA, SOPs, and company Best Practices Guidelines.• Provided appropriate training, mentoring and career development for staff of 17 FTEs in US, UK and Japan.

• Managed Global and US clinical trials in Pompe Disease.• Oversaw the preparation of documents such as study protocol, informed consent forms and study procedure manuals.• Drove timelines for project related tasks, including start up activities and study maintenance.• Managed resources and tasks within Pompe disease trials.• Organized and lead clinical trial team meetings.• Oversaw various vendors for the Pompe Studies.• Updated management on study progress as necessary.• Developed and mentored colleagues reporting to me.• Hired and trained new team members.

• Managed all aspects of a Global phase 1 clinical trial in Pompe Disease.• Prepared documents such as Informed Consent Forms and study procedure manuals.• Drove timelines for protocol development and site initiation visits.• Managed team responsibilities and tasks.• Organized regular clinical trial team meetings.• Managed various vendors for Phase 1/2 study.• Updated management on study progress as necessary.

• Manage clinical trial start-up activities, ongoing and close out activities of oncology studies in Phase I, II and Phase III in adult and pediatric clinical trials.• Write various clinical documents including protocols, amendments, Informed Consent Forms and Investigator Brochures.• Experience working on trials with solid tumors and blood cancer (ALL). Experience on trials in gene therapy trials(CART19).• Oversight and management of vendors during study start up through close out. Vendors included CRO, central laboratory and central ECG. • Review vendor proposals and budgets.• Data review and clean-up for Interim Analysis on pivotal trial.• Quality control of various documents related to FDA submission.• Participated in a pediatric initiative program to help other associates run trials with pediatric patients.• Participated as an onboarding partner for colleagues new to Novartis.• Mentored co-workers on various tasks.

• Generated weekly enrollment updates and forecasts.• Oversight and management of study vendors and Country Operations personnel in participating countries.• Tracked various aspects of clinical trials including date milestones, protocol deviations, Serious Adverse Events and various supplies using Microsoft (MS) Excel.• Organized Investigator Meetings in USA, Europe and South America.• Prepared oral presentations for Investigator Meetings as well as weekly team meetings and study updates.• Reconcile data between various systems to ensure proper reporting of study related data, including Trial Master File reconciliation and SAE database reconciliation.• Proficient in the use of InForm, Clinical Trial Management System (CTMS), MS Excel, MS Word, MS Project and MS Power Point.• Participated in the review of site compliance issues and audits.• Writing and/or reviewing various documents, including IB, Protocol, CSR, Monitoring Plan and ICF.• Point of Contact for monitoring related questions from Clinical Research Associates throughout the world.• Performed pre-study, initiation, interim, and close-out monitoring visit.

Scientist II, Antiviral Chemotherapy, 09/1990 to 08/2005• Proficient in many aspects of molecular biology including DNA sequencing and cloning. SNP detection using Pyrosequencing. Protein expression and purification in E. Coli. PCR, RT-PCR and quantitative RT-PCR using TaqMan Sequence detection system.• Assay development for HCV clinical trials using patient serum samples to sequence for drug induced mutations.• Responsible for training of new laboratory personnel in molecular biology techniques.• Experienced in tissue culture, cell counting, staining and viral plaque assays.• Preparation of scientific data for journal articles, patents, poster sessions and oral presentations.Assistant Scientist II, Allergy and Immunology, 03/1987 to 09/1990• Assisted in the setting up of a histology laboratory.• Screened potential antihistamine compounds in a variety of assays.Assistant Scientist I, Pathology, 11/1985 to 03/1987• Involved in all phases of the histological processes.• Monitoring of pathological studies. Trained in the recognition of clinical symptoms and physical abnormalities in a of a variety of species.

Adjunct Professor, Department of Biology• Nucleic Acid Sequencing course • Responsible for lecture lesson plans• Responsible for laboratory lesson plans.• The students learn all aspects of DNA sequencing and related topics, in this graduate level course.